The U.S. Food & Drug Adminstration (FDA) recently linked Topamax (generic: topiramate) to an increased risk of birth defects in children born to mothers that took the drug during pregnancy. More specifically, Topamax, the popular Epilepsy drug, which was also promoted “off-label” for psychiatric health has been linked to Cleft Lip and Cleft Palate birth defects.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Topamax induced injury cases in all 50 states. If you or somebody you know had a baby with a birth defect after taking Topamax during pregnancy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: $11 Million Topamax Jury Award Survives Appeal by Janssen
May 7, 2014 — A judge in Philadelphia has ruled that an $11 million award to the family of Brayden Gurley will survive appeal, and Janssen will not receive a new trial.
March 10, 2014 — A Pennsylvania jury has awarded $3 million to the family of 5 year-old Payton Anderson, a boy who was born with cleft lip. His mother took Topamax during pregnancy to treat migraine headaches. Click here to read more.
October 31, 2013 — Janssen Pharmaceuticals is facing 134 lawsuits in Philadelphia from women who took Topamax during pregnancy and had a baby with a birth defect. The first lawsuit was awarded $4 million by a jury that deliberated for less than an hour before finding Janssen liable for failing to warn about Topamax birth defects. Click here to read more.
FDA Issues Topamax Warning
On March 4, 2011 the FDA required the manufacturers of topiramate (Topamax) to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects, including cleft lip, cleft palate, and genital malformations including Hypospadias.
However, the FDA had known of the birth defect risk three years prior. In the July 2008 issue of Neurology, researchers reported that “Exposure to the antiepileptic medicine Topamax in the first trimester of pregnancy carried a higher-than-usual rate of congenital malformations.”
In the study titled, “Topiramate in pregnancy — Preliminary experience from the UK Epilepsy and Pregnancy Register”, researchers found that 13 out of 178 patients taking Topamax gave birth to children with birth defects.
Manufacturers Plead Guilty
This bold move by the FDA comes after years of “issues” for the drug and its manufacturers. In 2009 two Johnson & Johnson subsidiaries, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc, were accused by the Department of Justice of promoting the drug “off-label” to physicians for unapproved purposes. According to the settlement, the manufacturers of the brand name version Topamax plead guilty and paid a $6.14 million criminal fine and $75.37 million for violating the False Claims Act.
Birth Defects Linked to Topamax
- Cleft Lip
- Cleft Palate
- Other Birth Defects
Topamax Class Action Lawsuit Information
In May 2014, a judge in Philadelphia denied Janssen an appeal of an $11 million jury award in a Topamax lawsuit. The plaintiff, Brayden Gurley, was born with cleft palate and other birth defects after his mother took Topamax during pregnancy. The verdict is just one of several multi-million dollar jury awards against Janssen that have survived appeal. These cases are not part of a Topamax class action lawsuit — they are individual lawsuits that were filed on behalf of children with severe birth defects.
Do I Have a Topamax Lawsuit?
The Schmidt Firm, PLLC is currently accepting Topamax induced injury cases in all 50 states. If you or somebody you know had a baby with a birth defect after taking Topamax during pregnancy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
